Angioplasty device

Abstract

Provided is a catheter system for intraluminal passages, including blood vessels, which includes a guidewire incorporating a work element, and an inflatable balloon enveloping the work element. The work element includes a lesion-smoothing member which in a work configuration projects radially from a longitudinal axis of the balloon. The work element may be configured to allow for controllable rotation about the longitudinal axis, such that the rotation thereby substantially defines a closed ellipsoid-like surface. When the balloon is inflated with a fluid and is inside an intraluminal passage, rotation of the work element causes the lesion-smoothing member to rotate along a surface of the balloon and simultaneously push against the balloon surface. The pushing against the balloon surface exerts force against the walls of the intraluminal passage, thereby allowing for smoothing lesion material located on the walls of the intraluminal passage.

1 . A catheter system, comprising:
 a guidewire comprising a proximal segment, a distal segment, and at least one work element, being elongated and extending therebetween from a distal end of said proximal segment to a proximal end of said distal segment;   a tube, being flexible and mounted on said guidewire such that said proximal segment longitudinally extends therethrough; and   a balloon, being inflatable and enveloping said at least one work element, said balloon being connected at a balloon proximal end to said tube at a distal end thereof;   
       wherein said guidewire is controllably switchable between a guiding configuration, for maneuvering the catheter system through intraluminal passages, and a work configuration, in which said at least one work element radially projects relative to a longitudinal axis of said balloon and pushes against a surface of said balloon when said balloon is inflated with fluid and anchored in an intraluminal passage; and wherein said at least one work element is non-expandable. 
     
     
         2 . The catheter system of  claim 1 , wherein said at least one work element comprises a lesion-smoothing member, said lesion-smoothing member being a rigid or resiliently flexible surface or a rigid or resiliently flexible wire. 
     
     
         3 . The catheter system of  claim 2 , wherein in the guiding configuration said at least one work element substantially does not project relative to the longitudinal axis. 
     
     
         4 . The catheter system of  claim 2 , wherein said guidewire is continuously switchable between the guiding configuration and the work configuration, thereby allowing to control the amount of projection of said at least one work element and the amount of force exerted by said at least one work element against said balloon surface when said balloon is inflated with a fluid and anchored in an intraluminal passage. 
     
     
         5 . The catheter system of  claim 4 , wherein said at least one work element is further configured to allow for controllable rotation about the longitudinal axis, such as to allow said lesion-smoothing member to slide along said balloon surface and simultaneously push there against when said guidewire is in the work configuration and said balloon is inflated with a fluid and anchored in an intraluminal passage; and/or
 wherein said at least one work element is further configured to allow for reciprocal motion, such as to allow said lesion-smoothing member to substantially proximally and distally slide along said balloon surface and simultaneously push there against when said guidewire is in the work configuration and said balloon is inflated with a fluid and anchored in an intraluminal passage.   
     
     
         6 . The catheter system of  claim 5 , wherein said at least one work element is configured to allow for controllable rotation about the longitudinal axis, the controllable rotation being effected by rotating said proximal segment. 
     
     
         7 . The catheter system of  claim 6 , wherein the mounting of said balloon distal end on said distal segment is such as to prevent any proximal and distal motion of said balloon distal end relative to said distal segment. 
     
     
         8 . The catheter system of  claim 7 , further configured to allow switching from the guiding configuration to the work configuration by distally pushing said proximal segment when said balloon is anchored. 
     
     
         9 . The catheter system of  claim 8 , wherein said distal segment comprises an exposed segment and a non-exposed segment, located outside of said balloon and within said balloon, respectively, said exposed segment comprising a pliable tip at a distal end thereof. 
     
     
         10 . The catheter system of  claim 9 , wherein said tube distal end comprises a first bearing mounted thereon and connected to said balloon proximal end, said proximal segment passing through said first bearing; and wherein said distal segment comprises a second bearing mounted thereon and connected to said balloon distal end, said first bearing and said second bearing being configured to allow rotating said guidewire without rotating said tube and said balloon, said first bearing being further configured to allow proximal and distal motion therethrough of said proximal segment. 
     
     
         11 . The catheter system of  claim 10 , wherein said proximal segment comprises a first disc, mounted perpendicularly thereto and distally relative to said first bearing such as to be positioned adjacent thereto when said guidewire is in the guiding configuration, and wherein said distal segment comprises a second disc and a third disc, mounted perpendicularly thereto and proximally and distally relative to said second bearing, respectively, such as to be positioned adjacent thereto. 
     
     
         12 . The catheter system of  claim 11 , wherein said exposed segment and said non-exposed segment are mechanically associated via a ratchet within said second bearing, said ratchet being configured to allow for (i) joint rotation of said exposed segment together with said non-exposed segment, said at least one work element, and said proximal segment when said proximal segment is rotated in one sense, and (ii) rotation only of said non-exposed segment, said at least one work element, and said proximal segment when said proximal segment is rotated in the other sense. 
     
     
         13 . The catheter system of  claim 12 , wherein said lesion-smoothing member is substantially convex. 
     
     
         14 . The catheter system of  claim 13 , wherein said lesion-smoothing member is a convex surface, and wherein said at least one work element further comprises a first arm, mechanically associating said convex surface on a proximal end thereof with said distal end of said proximal segment, and a second arm, mechanically associating said convex surface on a distal end thereof with said proximal end of said distal segment. 
     
     
         15 . The catheter system of  claim 14 , further comprising a first joining region connecting said proximal segment distal end to said first arm, a second joining region connecting said first arm to said convex surface proximal end, a third joining region connecting said convex surface distal end to said second arm, and a fourth joining region connecting said second arm to said distal segment proximal end;
 wherein said joining regions comprise hinges, or said joining regions are more flexible than said proximal segment, said first arm, said convex surface, said second arm, and said distal segment, such as to allow said convex surface to be lifted when said proximal segment is pushed in the distal direction when said balloon is inflated with a fluid and anchored within an intraluminal passage.   
     
     
         16 . The catheter system of  claim 15 , further comprising a duct fluidly connected at a distal end thereof to said balloon and configured to be coupled, at a proximal end thereof, to a fluid source or vacuum, said duct being longitudinally joined at least at a distal portion thereof to said tube. 
     
     
         17 . The catheter system of  claim 16 , configured to allow for the controllable rotation to be effected by a motor and/or manually. 
     
     
         18 . The catheter system of  claim 5 , wherein the intraluminal passage is a blood vessel. 
     
     
         19 . The catheter system of  claim 5 , comprising a plurality of said work element, said plurality of work elements being symmetrically disposed about the longitudinal axis of said balloon. 
     
     
         20 . A method for treating blockage in intraluminal passages, comprising the steps of:
 introducing a catheter system, according to  claim 1 , into an intraluminal passage in a body of a subject, the catheter system being in the guiding configuration, and maneuvering the catheter system until the balloon reaches a location of a target lesion in the intraluminal passage, with the work element facing the target lesion;   inflating the balloon with a fluid until the balloon pushes against inner walls of the intraluminal passage, thereby anchoring the balloon;   switching the catheter system into the work configuration, thereby pushing the work element against the target lesion and compressing the target lesion.